MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PROXIMAL EXTENSION SIZE 7/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Model Number 04.641.057

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during a veptr revision surgery, due to the patient needing a longer growing rod, the surgeon noticed that the titanium proximal extension rod was malformed.There was no surgical delay.Procedure outcome is unknown.No patient consequence.This report involves one (1) ti proximal extension size 7/500mm radius.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary: photo investigation : the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, one end of the ti proximal ext size 7/500mm radius was observed to be broken.Thus, the reported complaint condition is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition is being confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: mre was not performed as the lot number is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PROXIMAL EXTENSION SIZE 7/500MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11581312
• MDR Text Key: 244936581
• Report Number: 2939274-2021-01553
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034750156
• UDI-Public: (01)10705034750156
• Combination Product (y/n): N
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.641.057
• Device Catalogue Number: 04.641.057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Patient Sequence Number: 1